To break patent or not to break patent

In September, the United Nations High-Level Panel on Access to Medicines released a controversial report recommending that low-income countries break patent on medicines (e.g. exercise Trade-Related Aspects of Intellectual Property Rights, or TRIPS, flexibilities) as needed to meet national health goals, and that new models of financing drug research and development (R&D) should be explored. Panel Co-Chair Ruth Dreifuss of Switzerland says, ‘The lessons learned from the fight to access antiretroviral therapy inspired the High-Level Panel and brought us to strongly encourage countries to use the TRIPS flexibilities and to make public health assessments when negotiating free trade agreements. We hope the civil society will be more aware about what is at stake when such treaties are in discussion.’ Panelist Michael Kirby of Australia explains, ‘Never before the High-Level Panel has there been an effective global study of the reconciliation between the right to healthcare (under universal human rights law) and the right of authors to just rewards for sharing their inventions with society (under international intellectual property law). Now we have a blueprint to ensure that these two objectives of the international community will be reconciled in a way that harmoniously respects and upholds each legitimate international goal and keeps them in proper equilibrium.’ The US government expressed disappointment with the report, issuing a statement that read, ‘The Panel has now concluded its work and missed a key opportunity to provide practical observations regarding the complex issues surrounding access to medicines. The Report instead offers only a narrow perspective on a subset of those issues and articulates divisive policies that, if implemented, could severely undermine the innovation critical for the development of medicines and health technologies as well as private sector, university, and government-funded research.’ However, other parties have cheered the Panel's recommendations. Judit Rius (US Manager, Access Campaign, Médecins Sans Frontières) says, ‘The groundbreaking recommendation of the report is asking governments to increase transparency on pricing and R&D costs and change incentives for innovation so they break the link between R&D costs and the high prices of medicines.’ Given its focus on intimidation as the main barrier for the use of TRIPS flexibilities, what might the practical effects of the Panel's report be? Nitsan Chorev (Professor, Brown University) notes that while fear of punishment and intimidation are important barriers for low-income countries considering breaking patent, another important consideration is the bureaucratic challenges embedded in the TRIPS agreement and related declarations. She also notes that most antiretrovirals in sub-Saharan African countries are purchased by the Global Fund/PEPFAR, both of which have been criticized for underutilization of TRIPS flexibilities. Thus, if a global, systematic solution is desired, these programs should be part of the conversation. However, she says, ‘The fact that lives won’t change right away doesn’t on its own undermine the importance of the Report. This is a symbolic, nonbinding, nonobligatory exercise. But this Report provides awareness and legitimacy – weapons – for those who can make things happen.’ Acknowledgements Conflicts of interest There are no conflicts of interest.

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